Technician IV, Bio / Pharma Production
Boehringer Ingelheim
- Fuquay-Varina, NC Georgia
- Permanent
- Full-time
- Perform duties associated with aseptic processes, weighing, measuring, counting, calculations, sampling, and verifications required for biological production processes in accordance with batch production records (BPR) and in compliance with current good manufacturing practice (cGMP) standards, all current safety standards and site procedures.
- Has mastered the operation of production equipment and ensures all equipment, instruments, and production materials are released and available for use. Look up and perform transactions within the electronic inventory management system.
- Performs all equipment and process troubleshooting
- Authority over all production processes, cleaning, environmental monitoring and personnel and perform in-process batch quality checks per the written procedures. Knows and follows safety rules, wears appropriate safety equipment and maintains proper safety practices at all times.
- *BL-3 technicians are required to participate in the BIAH Encephalomyelitis Program without health restrictions.
- Extensive computer skills to create and update standard operating procedures and write deviation reports, and to complete all training as assigned to include general company procedures, area procedures, equipment operation, computer operation, safety, GMP, BPE, and other as needed.
- A leader in generating or collecting new ideas about workplace and processes.
- Required to apply knowledge in the training of others.
- Performs all Company business in accordance with all regulations (e.g., USDA, OSHA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrated high ethical and professional standards with all business
- contacts in order to maintain BIAH´s excellent reputation in the community.
- Bachelors degree from an accredited institution in Microbiology or other related Science, plus three (3) years of experience; OR an Associates degree from an accredited institution in Microbiology or other related Science, plus five (5) years of experience; OR a High School diploma, plus seven (7) years of experience.
- Advanced computer skills with Word, Excel and Electronic Management Systems (SAP), extensive biological equipment knowledge and/or experience (i.e. fermentation, centrifuge, concentration units), basic understanding of biological organisms.
- Interpret and conform to batch records, Quality and Safety requirements.
- Operational knowledge with FDA, USDA, EU, and EPA regulations.
- Advanced ability to assist maintenance and process engineering in troubleshooting.
- Complies with all the business compliance requirements of current Good Manufacturing Practices (cGMP), Housekeeping, Environmental, Safety, and Security.
- Ability to operate applicable ERP system.
- Requires extensive knowledge of manufacturing function, acquaintance with and general understanding of detailed aspects of the production process and ability to apply this knowledge to problems and situations ordinarily encountered.